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Orion publishes Interim Report for January–September 2022 on Thursday 20 October 2022

On October 6, 2022 Orion reported that it will publish Interim Report for January–September 2022 on Thursday, 20 October 2022 at approximately 12.00 noon EEST (Press release, Orion , OCT 6, 2022, View Source [SID1234621791]). The report and related presentation material will be available on the company’s website at www.orion.fi/en/investors after publishing.

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Webcast and conference call

A webcast and a conference call for analysts, investors and media will be held on Thursday, 20 October 2022 at 13.30 EEST. The event will be held only online and by conference call.

A link to the live webcast will be available on Orion’s website at www.orion.fi/en/investors. A recording of the event will be available on the website later the same day.

Imugene’s onCARlytics to be showcased in three abstracts at SITC Annual Meeting

On October 6, 2022 Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, reported that its onCARlytics (CF33-CD19) oncolytic virus technology will be featured in three abstracts at the renowned Annual Meeting for the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), to be held in Boston, USA on 8-12 November 2022 (Press release, Imugene, OCT 6, 2022, View Source [SID1234621790]).

Known as one of the most prestigious immunotherapy events on the calendar, SITC (Free SITC Whitepaper) 2022 will feature cuttingedge research presentations by various experts, oral, and poster abstract presentations and various opportunities for networking and discussion with members of the oncology community.

The abstract titles were released at 8am EDT (US Eastern Daylight Time) 5 October 2022, with those featuring Imugene’s onCARlytics as follows:

Title: Combination immunotherapy using a novel chimeric oncolytic virus to redirect CD19 bispecific T cell engagers to target solid tumors Abstract #: 305 Title: CF33-CD19t oncolytic virus (onCARlytics) targets hepatocellular carcinoma (HCC) and in combination with Artemis CD19 T cells results in significant tumor killing Abstract #: 368

Title: CF33-CD19t oncolytic virus (onCARlytics) in combination with off-the-shelf allogeneic CyCART-19 T cells targeting de novo CD19+ solid tumors Abstract #: 847

Imugene will announce further detail from these abstracts at the time of the event.

onCARlytics is a CD19-expressing oncolytic virus that enters tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for CD19 targeting therapies. Imugene exclusively IMUGENE LIMITED ACN 009 179 551 2 licensed the technology from City of Hope, one of the largest cancer research and treatment organisations in the US.

Sigyn Therapeutics™ Announces Cancer-Related Patent Submission Entitled: “System and Methods to Enhance Chemotherapy Delivery and Reduce Toxicity”

On October 6, 2022 Sigyn Therapeutics, Inc. ("Sigyn" or the "Company") (OTCQB: SIGY), a development-stage company focused on creating therapeutic solutions to address unmet needs in global health, reported that a provisional patent application entitled: "SYSTEM AND METHODS TO ENHANCE CHEMOTHERAPY DELIVERY AND REDUCE TOXICITY" has been filed with the United States Patent and Trademark Office ("USPTO") (Press release, Sigyn Therapeutics, OCT 6, 2022, View Source [SID1234621788]).

Cancer is the second leading cause of death in the United States1. Despite therapeutic advances, treatment toxicity, drug resistance and inadequate tumor site delivery restrict the benefit of chemotherapeutic agents administered to cancer patients. More specifically, less than 5% of systemically administered chemotherapeutic agents are reported to reach their target tumor site2,3. Off-target chemotherapeutic agents contribute to treatment toxicity2,3 and may promote the spread of cancer metastasis4,5,6,7,8.

To overcome these challenges, Sigyn’s patent submission describes a therapeutic device system whose primary objective is to enhance chemotherapy delivery and reduce its toxicity. A secondary objective of the therapeutic system is to reduce treatment dosing without sacrificing patient benefit, or conversely increase chemotherapy dosing without added toxicity. In concert with these objectives, the therapeutic system offers to reduce drug resistance and inhibit the potential spread of cancer metastasis induced by the administration of chemotherapeutic agents.

"This patent submission is dedicated to friends and family members whose lives were taken by cancer," stated Jim Joyce, CEO of Sigyn Therapeutics and the inventor underlying the patent submission. "Additionally, as we advance Sigyn TherapyTM to address life-threatening conditions that are beyond the reach of drugs, I want to clarify that the intent of this patent submission is to protect the development of a therapeutic system to improve the benefit of chemotherapeutic drugs already approved to treat cancer," concluded Joyce.

On September 14, 2022, the Company announced plans to initiate first-in-human studies of Sigyn Therapy in End-Stage Renal Disease (ESRD) patients suffering from excess inflammation and/or endotoxemia. Sigyn Therapy is a broad-spectrum blood purification technology designed to treat pathogen-associated inflammatory disorders that are not addressed with approved drug therapies. Candidate treatment indications for Sigyn Therapy also include sepsis, community acquired pneumonia and emerging pandemic threats.

GT Biopharma Announces Two Poster Presentations at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting

On October 6, 2022 GT Biopharma, Inc. (the "Company" or "GTB") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE platform, reported two poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 37th Annual Meeting (SITC 2022), to be held in Boston, Massachusetts and virtually on November 8-12, 2022 (Press release, GT Biopharma, OCT 6, 2022, View Source [SID1234621787]). The two posters will highlight preclinical data on tri-specific NK cell engagers for the treatment of mesothelioma and prostate cancer.

Poster Presentations

Title: Tri-specific killer engagers target natural killer cells towards mesothelioma
Abstract Number: 1202
Presenter: Pippa Kennedy and Martin Felices
Date: November 11, 2022
Location and time: Poster Hall from 9:00am – 8:30pm ET

Title: Enhancing NK cell function in the ‘cold’ tumor microenvironment of prostate cancer with a novel Tri-specific Killer Engager against prostate-specific membrane antigen (PSMA)
Abstract Number: 1204
Presenter: Shee Kwan Phung and Martin Felices
Date: November 11, 2022
Location and time: Poster Hall from 9:00am – 8:30pm ET

About SITC (Free SITC Whitepaper)

Established in 1984, the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is a nonprofit organization of medical professionals dedicated to improving cancer patient outcomes by advancing the development, science and application of cancer immunotherapy and tumor immunology. SITC (Free SITC Whitepaper) is comprised of influential basic and translational scientists, practitioners, health care professionals, government leaders and industry professionals around the globe. Through educational initiatives that foster scientific exchange and collaboration among leaders in the field, SITC (Free SITC Whitepaper) aims to one day make the word "cure" a reality for cancer patients everywhere. Learn more about SITC (Free SITC Whitepaper) at sitcancer.org.

Kiromic BioPharma Announces FDA Feedback from Type B Pre-IND Meeting Confirms Deltacel Development Strategy

On October 6, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully-integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell and gene therapies with a focus on immuno-oncology, reported it received validating written feedback on October 4, 2022 from the FDA pursuant to its Type B Pre-IND meeting request regarding its Deltacel development strategy (Press release, Kiromic, OCT 6, 2022, View Source [SID1234621786]).

The purpose of the Pre-IND meeting request was to seek alignment with and to obtain FDA guidance on Kiromic’s proposed development strategy about the chemistry, manufacturing, and controls (CMC), nonclinical studies, and clinical study plan for Deltacel/KB-GDT for treating subjects with Non-Small Cell Lung Cancer (NSCLC). Kiromic will leverage this FDA Pre-IND written confirmatory feedback and recommendations into a robust IND submission package for a projected clinical trial launch in Q1 2023.

"We are delighted to receive this very productive feedback about Deltacel/KB-GDT from the FDA, confirming our development strategy for this therapeutic candidate," stated Pietro Bersani, Chief Executive Officer of Kiromic. "It was a strategic decision to focus on metastatic stage 4 lung cancer as our first indication in addressing solid malignancies, and we are very heartened to be continuing to fulfill our mission to address solid malignancies, which represent more than 90% of all cancers."

Further reiterating Management’s focus on executing the Deltacel-aligned development strategy, the Company has streamlined its operations and aligned key resources to advance its Deltacel product candidate while maintaining its other product candidates Procel and Isocel. As part of that aligned strategy and following a thorough evaluation to maximize operational efficiencies, Kiromic’s management made the difficult yet necessary decision to eliminate 20 positions or approximately 29% of its workforce. The Company believes these key actions and overall strategy align with financing options it is actively pursuing.

"Deltacel is our most advanced therapeutic candidate, and its use of allogeneic, non-viral, non-engineered off-the-shelf Gamma Delta T-cells (GDT) is a next-generation solution for patients. As such, this prioritization also mitigates supply-chain challenges associated with a virus-based approach. We believe these advantages will allow us to efficiently establish the platform’s safety and tolerability and build upon Deltacel’s previously demonstrated preclinical efficacy across multiple indications. With the FDA guidance in hand, we believe we’ve further strengthened our case to align operations with Deltacel and deliver value sooner to our shareholders," commented Bersani.